On Thu, 17 Apr 2003 16:18:23 -0400
"Paul, David A" <paulda at battelle.org> wrote:
At Battelle, the QA/QC folks have the philosophy that the FDA will likely hold us responsible for whatever internal standards we set for ourselves, assuming that such standards are "reasonable". For software, our internal standards basically say that (1) COTS (Com'l Off The Shelf software) developed by a company having both a long history of selling high-quality products and good QA doesn't need extensive from-scratch validation, only validation of simpler routines like the computation of means, variances, linear regression models, &etc. (After all, how would anyone really validate what, say, PROC NLMIXED yields in a complex growth-curve application?)
You can validate much of that using simulation, which is not done often enough in my opinion.
(2) Anything free needs to be extensively validated by comparing it with something that fits into (1) This leaves R completely out of our GLP studies, and favors SAS since Insightful hasn't been around as long as the SAS Institute. Like it or not, the perception is that using SAS won't get you into trouble with the FDA or other regulatory agencies.
- David Paul
Since you have the option of validating free software against COTS your conclusion does not make sense to me. And to reiterate, the perception that SAS won't get you into trouble, or more accurately speaking, the perception that non-SAS software will get you into trouble with the FDA, is only a perception. The FDA has no guidelines on that. And why should closed-source software be so trusted anyway? --- Frank E Harrell Jr Prof. of Biostatistics & Statistics Div. of Biostatistics & Epidem. Dept. of Health Evaluation Sciences U. Virginia School of Medicine http://hesweb1.med.virginia.edu/biostat